search
Back to results

OPTImal Management of Antithrombotic Agents: OPTIMA-5

Primary Purpose

Acute Coronary Syndrome (ACS)

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Switch ticagrelor to clopidogrel
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome (ACS) focused on measuring Dual antiplatelet therapy (DAPT), Platelet function, Clopidogrel, Ticagrelor, Switch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 18 years.
  • ACS patients.
  • Patients who are treated with ticagrelor and do not tolerate it.
  • Volunteer to participate and sign informed consent.
  • Approved by national regulatory authorities ethics committees.

Exclusion Criteria:

  • Patients who are contraindicated, intolerant or resistant to clopidogrel.
  • History of hematological disease or bleeding tendency; platelet count < 100 × 10^9 cells/L, or > 600 × 10^9 cells/L, hemoglobin < 100 g/L.
  • Abnormal liver or kidney function (ALT > 3 ULN; estimated CrCl < 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease.
  • Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole.
  • Malignancies or other comorbid conditions with life expectancy less than 1 year.
  • Pregnant or lactating woman.

Sites / Locations

  • First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

clopidogrel-600 mg-12h

clopidogrel-600 mg-24h

clopidogrel-75 mg-12h

clopidogrel-75 mg-24h

Arm Description

clopidogrel 600 mg loading dose (LD) 12 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily

clopidogrel 600 mg loading dose (LD) 24 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily

clopidogrel 75 mg maintenance dose(MD) 12 hours after the last MD of ticagrelor

clopidogrel 75 mg maintenance dose（MD) 24 hours after the last MD of ticagrelor

Outcomes

Primary Outcome Measures

Change of platelet aggregation between different time points
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).

Secondary Outcome Measures

Rate of clinical endpoint event
Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.

Full Information

First Posted
September 26, 2019
Last Updated
August 21, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04116931
Brief Title
OPTImal Management of Antithrombotic Agents: OPTIMA-5
Official Title
A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.
Detailed Description
The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry method(LTA). Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome (ACS)
Keywords
Dual antiplatelet therapy (DAPT), Platelet function, Clopidogrel, Ticagrelor, Switch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
clopidogrel-600 mg-12h
Arm Type
Experimental
Arm Description
clopidogrel 600 mg loading dose (LD) 12 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily
Arm Title
clopidogrel-600 mg-24h
Arm Type
Experimental
Arm Description
clopidogrel 600 mg loading dose (LD) 24 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily
Arm Title
clopidogrel-75 mg-12h
Arm Type
Experimental
Arm Description
clopidogrel 75 mg maintenance dose(MD) 12 hours after the last MD of ticagrelor
Arm Title
clopidogrel-75 mg-24h
Arm Type
Experimental
Arm Description
clopidogrel 75 mg maintenance dose（MD) 24 hours after the last MD of ticagrelor
Intervention Type
Drug
Intervention Name(s)
Switch ticagrelor to clopidogrel
Other Intervention Name(s)
switch
Intervention Description
Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose（MD）12/24 hours after the last MD of ticagrelor
Primary Outcome Measure Information:
Title
Change of platelet aggregation between different time points
Description
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
Time Frame
baseline,4 hours,8 hours,24 hours,48 hours,72 hours
Secondary Outcome Measure Information:
Title
Rate of clinical endpoint event
Description
Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years. ACS patients. Patients who are treated with ticagrelor and do not tolerate it. Volunteer to participate and sign informed consent. Approved by national regulatory authorities ethics committees. Exclusion Criteria: Patients who are contraindicated, intolerant or resistant to clopidogrel. History of hematological disease or bleeding tendency; platelet count < 100 × 10^9 cells/L, or > 600 × 10^9 cells/L, hemoglobin < 100 g/L. Abnormal liver or kidney function (ALT > 3 ULN; estimated CrCl < 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease. Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole. Malignancies or other comorbid conditions with life expectancy less than 1 year. Pregnant or lactating woman.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunjian Li, Dr, PhD
Phone
+86-13701465229
Email
drcjli@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Gu
Phone
+86-18351972592
Email
Solsticeg@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunjian Li, Dr, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuming Zhang, M.D.
Phone
+86-25-83718836
Ext
6360
Email
jsphkj@163.com
First Name & Middle Initial & Last Name & Degree
Yi Chai, M.D.
Phone
+86-25-83718836
Ext
6360
Email
jsphkj@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

OPTImal Management of Antithrombotic Agents: OPTIMA-5

We'll reach out to this number within 24 hrs